Diphenoxylate Hydrochloride and Atropine Sulfate
Approved
Approval ID
47b65bb8-8501-448c-aecd-b41c8efb4241
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2012
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diphenoxylate hydrochloride and atropine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66336-437
Application NumberANDA085762
Product Classification
M
Marketing Category
C73584
G
Generic Name
diphenoxylate hydrochloride and atropine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2012
FDA Product Classification
INGREDIENTS (6)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB